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NCT03218163 · ADVERSE EVENTS

Adverse events

MEDI-551 as Maintenance Therapy After Allogeneic Stem Cell Transplant in Multiple Myeloma · Source last updated 2019-01-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
For the duration of the study, about 7 months.
Other-event reporting threshold
0%

One participant was enrolled but did not receive study treatment. The participant was monitored for adverse events since enrollment into study (signing informed consent).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
MEDI-551 Treatment Arm

Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons. MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV

0 / 10 / 10 / 1

Group identifiers: EG000: MEDI-551 Treatment Arm

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      description
      One participant was enrolled but did not receive study treatment. The participant was monitored for adverse events since enrollment into study (signing informed consent).
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        1
        description
        Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons. MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        1
        serious Num Affected
        0
        serious Num At Risk
        1
        title
        MEDI-551 Treatment Arm
      frequency Threshold
      0
      time Frame
      For the duration of the study, about 7 months.

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice